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Compares treatment options for Rhinovirus Infection
Official title Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD
ClinicalTrials.gov ID: NCT07610395
What this study is testing
What is VPV 1000 mg?
VPV 1000 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for rhinovirus infection.
Also referred to as Vapendavir.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Compare the safety and efficacy of two different oral vapendavir doses with placebo in order to determine the appropriate dose of vapendavir to reduce the severity and/or duration of respiratory symptoms associated with RV infections in patients with COPD.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- Inclusion Sign informed consent for study participation and medical records release (if needed). Male or female age ≥40 years and ≤85 years at the...
- AECOPD is defined as an event characterized by dyspnea and/or cough and increased sputum purulence/change in sputum color that worsens over several...
- Increase frequency or dose of beta agonist(s), oxygen, breathing treatments or chronic COPD medications (Mild Exacerbation)
- Use of oral or systemic steroids (Moderate Exacerbation), or
- Use of Antibiotics (Moderate Exacerbation), or
You likely can't join if
- to be assessed only at Randomization:
- It is already determined, based on the Investigator's clinical judgement, that the participant will likely need antibiotics and/or oral steroids at...
- On or within 7 days prior to randomization, there is another active diagnosed infection with viral or bacterial pathogens (i.e., urinary tract...
See the full eligibility criteria
- Inclusion Sign informed consent for study participation and medical records release (if needed). Male or female age ≥40 years and ≤85 years at the time of signing the informed consent at Screening. If sexually active...
- AECOPD is defined as an event characterized by dyspnea and/or cough and increased sputum purulence/change in sputum color that worsens over several days, and requires at least one of the following for at least 2 days:
- Increase frequency or dose of beta agonist(s), oxygen, breathing treatments or chronic COPD medications (Mild Exacerbation)
- Use of oral or systemic steroids (Moderate Exacerbation), or
- Use of Antibiotics (Moderate Exacerbation), or
- Emergency room visit or hospitalization (Severe Exacerbation). CAT score ≥10 at screening. Able to comply with all study requirements, including the use of a mobile application to complete daily PROs, perform nasal...
- Chronic oral/systemic steroids \>10 mg per day (inhaled corticosteroids are permitted).
- Continuous oxygen via nasal cannula of \>2 L/min at the time of Screening or during the Asymptomatic Phase. (Participants on continuous oxygen may have the rate increased during physical exercise/ exertion or to cover...
- to be assessed only at Randomization:
- It is already determined, based on the Investigator's clinical judgement, that the participant will likely need antibiotics and/or oral steroids at the Day 1 Randomization Visit.
- On or within 7 days prior to randomization, there is another active diagnosed infection with viral or bacterial pathogens (i.e., urinary tract infection, cellulitis, etc.) that requires treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Tempe, Arizona, United States
- Newport Beach, California, United States
- San Diego, California, United States
- Miami Lakes, Florida, United States
- Snellville, Georgia, United States
- Valparaiso, Indiana, United States
- Lutherville, Maryland, United States
- Brooklyn, New York, United States
- Kings Mountain, North Carolina, United States
- Columbus, Ohio, United States
- DuBois, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Anderson, South Carolina, United States
- Rock Hill, South Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tempe, Arizona, United States; Newport Beach, California, United States; San Diego, California, United States; Miami Lakes, Florida, United States; Snellville, Georgia, United States; Valparaiso, Indiana, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.